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Vac-Assist Suction Units (SUA01 Suction Aspirator Unit… recallZ-2642-2014 · EMG Technology Co., Ltd. · initiated Aug 3, 2014

Class II Terminated All recalls posted in September 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from EMG Technology Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

suction canister lids may have occluded ports.

FDA root cause category: Nonconforming Material/Component

What the company is doing

A recall letter, dated August 6, 2014, was sent via email which identified the product, problem, and actions to be taken.

Recall details

Recall number
Z-2642-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 3, 2014
Posted by the FDA
Sep 13, 2014
Recalling firm
EMG Technology Co., Ltd.
Quantity
1452
Product code
JCX
FDA submissions
K042349
Distribution
US Distribution in IL.

Product description

Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.

Code information (models, lots, serial numbers)

Product Model No: SUAOI Serial Number ranges: SUI4B01391-SU14B02117. SU14C00556-SU14C01280

Other devices under the same FDA submission

1 device cleared under K042349 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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